FDA.reportPublic FDA data

Application 202765

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL200MGNoNo
002BENZONATATEBENZONATATECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4968BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-4969BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
50090-5823BenzonatateBenzonatateA-S Medication SolutionsANDACurrent
51224-001BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
51224-001BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
51224-001BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
51224-010BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
51224-010BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
51224-010BenzonatateBenzonatateTAGI Pharma, Inc.ANDACurrent
61919-763BENZONATATEBENZONATATEDIRECT RXANDACurrent
63187-606BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-606BenzonatateBenzonatateProficient Rx LPANDACurrent
63187-606BenzonatateBenzonatateProficient Rx LPANDACurrent
63629-2473BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2473BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2473BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2474BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2474BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2474BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2475BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2475BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2475BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2476BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2476BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-2476BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
63629-9189BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
67296-1290BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1290BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1290BenzonatateBenzonatateRedPharm Drug, Inc.ANDACurrent
68071-2624BenzonatateBenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6839BenzonatateBenzonatatePreferred Pharmaceuticals Inc.ANDACurrent
70518-3542BenzonatateBenzonatateREMEDYREPACK INC.ANDACurrent
70934-055BenzonatateBenzonatateDenton Pharma, Inc.ANDACurrent
70934-055BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-055BenzonatateBenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0031BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-0031BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-0031BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-1968BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71335-1968BenzonatateBenzonatateBryant Ranch PrepackANDACurrent
71626-201BenzonatateBenzonatateMedstone Pharma LLCANDACurrent
71626-201BenzonatateBenzonatateMedstone Pharma LLCANDACurrent
82982-023BenzonatateBenzonatatePharmasource Meds, LLCANDACurrent